FDA 483 - Quality Packaging Specialists International, LLC - October 03, 2025

An FDA inspection of Quality Packaging Specialists International, LLC in Burlington, NJ, revealed significant deficiencies in laboratory operations. Observations included inadequate review of laboratory records for accuracy and completion, as well as a lack of proper qualification and validation for electronic equipment like the LIMS and a stability chamber. These findings indicate a need for improved quality control and data integrity practices.